Parexel Blog

Parexel Blog

  • Challenges of 2020: Lessons for Clinical Trials in Diabetes

    Challenges of 2020: Lessons for Clinical Trials in Diabetes

    The extraordinary challenges of 2020—the global pandemic and the renewed campaign against racial injustice—have simultaneously presented opportunities for significant growth and change across the...

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  • Fostering steady advances in data operations: FSP partnerships can spur and support change

    Fostering steady advances in data operations: FSP partnerships can spur and support change

    When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly...

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  • The long and winding road for quality metrics takes another turn

    The long and winding road for quality metrics takes another turn

    In the latest turn of the long and winding road for quality metrics, FDA recently published invitations for industry to participate in two pilot programs for quality management maturity (QMM).

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  • Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    Threading the Eye of the Needle – FDA Sets Up a New Program for Importing Certain Products

    This blog focuses on unpacking the important points made in the companion Guidance for Industry – Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and...

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  • Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Early Demise of FDA is Exaggerated – Highlights from the FDLI Annual Meeting

    Despite the best efforts of the pandemic, the FDLI delayed but did not cancel its annual meeting for 2020 and hosted the event through a virtual platform. In this blog, I’ll walk through the...

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  • The Evolving Cell and Gene Therapy (CGT) Sector in China

    The Evolving Cell and Gene Therapy (CGT) Sector in China

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  • Optimizing SOPS in the Digital World

    Optimizing SOPS in the Digital World

    For any company on the receiving end of an FDA 483 or warning letter, standard operating procedures (SOPs) represent an opportunity to simultaneously achieve compliance and improve operational...

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  • Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

    Never Too Late to Join the Party – FDA Publishes Extensive Guidance on Control of Nitrosamine Impurities

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  • I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    I Can See More Clearly Now – FDA Issues Needed Guidance on Inspection Policies During COVID-19

    FDA has previously made several public statements about its ability to conduct inspections and FDA personnel have also made policy comments in various public forums. Now that this guidance has...

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  • An overview of the recent Executive Order on Critical Drugs Made in America

    An overview of the recent Executive Order on Critical Drugs Made in America

    The EO creates several new requirements aimed at building reliable, long-term domestic production of essential drugs and devices, including their components and input materials. These include...

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  • Successful wearable device selection for the evolving clinical trials landscape

    Successful wearable device selection for the evolving clinical trials landscape

    There are a plethora of different devices available, ranging from commercially available actigraphy to specialized and medically approved devices. This article is designed to help sponsors...

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  • The Move Toward Global Standards: Navigating New EAEU Guidelines

    The Move Toward Global Standards: Navigating New EAEU Guidelines

    Our regulatory affairs experts outline the new EAEU guidelines, and an effort to create global standards across the board. Read more...

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  • The Special Approval Pathway (SAP) for COVID-19 related products in China

    The Special Approval Pathway (SAP) for COVID-19 related products in China

    Since the COVID-19 pandemic began in early 2020, the Center for Drug Evaluation (CDE) has maximized its capacity and optimized its regulatory procedures within the SAP framework to accelerate...

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  • NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020

    Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...

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  • Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

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  • GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”

    With the continued threat of COVID-19, the way inspections will be performed and hosted will be significantly different from the pre-pandemic situation.

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  • Will the FDA “CARE” More About Your Supply Chain?

    Will the FDA “CARE” More About Your Supply Chain?

    On March 27, 2020 the president of the United States signed into law the Coronavirus Aid, Relief and Economic Security (CARES) Act in response to the emerging pandemic. The section of the act...

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  • Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Amy McKee, Vice President Regulatory Consulting Services, addresses some of the most common misconceptions about working with the FDA.

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  • Has EMA Started A Domino Effect For More Regulation Of Active Pharmaceutical Ingredients (API) Manufacturing?

    Has EMA Started A Domino Effect For More Regulation Of Active Pharmaceutical Ingredients (API) Manufacturing?

    On June 23, 2020 the European Medicines Agency (EMA) released a report on lessons learned from the presence of N-nitrosamine impurities in angiotensin II receptor blocker drugs. The summary of the...

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  • The future is now: Decentralized clinical trials during the pandemic and beyond

    The future is now: Decentralized clinical trials during the pandemic and beyond

    Enabling patients to participate in clinic trials from home is both important to maintain patient safety and data quality in ongoing trials and critical for many new trials as we plan for COVID-19.

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